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Summary

Self -starter, versatile and skilled Biotechnologist, possessing wide experience in analytical techniques with focus on molecular biology and  immunochemistry. Fast learner with the ability to set and achieve challenging goals. Revealing global approach to pharmaceutical and MD manufacturing, offering extensive experience in GLP regulated environment. Highest quality focused, solution based thniker with an innovate approach to challenging tasks. Efficient in assays development and data analyzing through logical and investigational approach.                                                                                                                                                                                                            A person, who demonstrates strong interest in pharmaceutical product development and manufacturing, assays development and molecular diagnosis. Also a team player with excellent interpersonal skills. Always achieving targets and completing tasks before deadline by excellent work organization, proper hierarchy of activities, top performance, sress resistance and lean thinking. Being aware of her high potential, she's focused on challenging, stimulating positions. 

Experiences

Current Experience

  • medical technologist Zaventem, Belgium
    Since January 2016

Past Experience

  • R&D Technician
    August 2013 --- November 2013

    Taking part in delivery innovation solution in molecular infection disease and oncology as rapid molecular assay for qualitative differential detection of BCR-ABL fusion transcripts and also infectious disseases. Assisting in sensitivity, specificity and robustness study of developed assays as well as stability study of molecular components (dNTPs, DNA primers, sample and enzymes solutions). Performing Q-LAMP assay (isothermal amplification technology) using Liaison Iam analysers (Iam Parvo, Iam VZV, Iam Toxo, Iam Hsv, Iam BKV, Iam CSV). Assisting in technical support issues, checking and verifying raw data of analytical results, maintaining data files. DNA extraction using Liaison Xt instrument employing the magnetic beads system, preparing and handling with variety types of biological samples (urine, plasma, CSF and amniotic fluid). Equipment maintenance (pipettes, balances, pH meter calibration, water purifier and TCU maintenance), preparing LAMP buffers, plasmid solutions, RNAse free water and other stock.

  • Student Dublin, ITT
    December 2012 --- May 2013

    Special Award Upskilling Programme in Pharmaceutical and Medical Device Manufacturing

    Main Modules: Bioprocess technology, Process Chemistry, Aseptic Technique, System Validation,GMP and Regularory Afffairs, PAT, QRM, Medical Devices Manufacturing. Lean Simulation, VSM.

  • Laboratory Analyst (Clinical Lab)
    October 2011 --- June 2012

    Carried out analytical biochemistry assays –ELISA, IFA to detect HBV, HCV, EBV and also others auxiliary analytical techniques for serum, plasma and urine specimens. Performing qPCR to multiply, determination and identification the targeted genetic sequence and also SDS PAGE and Western Blot for protein prolfiling.

    Reviewing of data and analytical results, investigation for non conformance, deviations and failures, aplication of CAPA as process implementation.

    Maintaining data files, records keeping and documentations review.

  • Laboratory Technician
    July 2008 --- March 2009
    A leading role in successful reassessment audit carried out by United Kingdom Accreditation Service (UKAS) in Feb 2009 in Alcontrol Laboratory followed by completed validation program for COD method. Conducted wet chemistry tests of water and soils samples according to ISO 17025, determination of such parameters as COD, ASS, Sulphites, Kjeldahl Nitrogen, elaborating and interpreting analytical results through LIMS, calibrating of instruments.

Personality

Self Assessment :
AdaptabilityAnalytical thinkingAttention to detailProblem solvingCompetitivenessEfficiencySelf-disciplineStrategic thinkingCreative thinkingCollaborationInterest in knowledgeCommunicativeCoordinationFlexibilityIndependenceInnovative thinkingKindnessOrientationProactivityResult OrientedSelf-confidenceService orientedTrust

Knowledge

Self Assessment :
Biochemistry Cell biology Labtechnician Medical devices R&DAnalytical techniquesAntibodiesBiotechnologyCAPAClinical researchDNA extractionDrug Safety and PharmacovigilancePCRQuantitative PCR (qPCR)ELISAWestern BlottingSOPFluorescence MicroscopyImmunohistochemistry (IHC)Allergy and immunologyAnalytical ChemistryAssay developmentBiochemistryBiopharmaceuticalsCell Based AssaysChemistryClinical DevelopmentClinical pharmacologyData AnalysisData entryDiagnosticsDNADrug development processDrug metabolismDrug regulatory authoritiesDrug safety assessmentDrug substance developmentEnglishEnzyme-linked immunosorbent assay (ELISA)Flow CytometryFDAFluorescent microscopyFormulationsGel ElectrophoresisGeneticsGood Laboratory Practice (GLP)GMPGood Manufacturing Practice (GMP)ImmunoassaysImmunologyIn VitroIn VivoInfectious diseasesLaboratoryLaboratory ResearchLaboratory TechniquesLaboratory testingMedical DevicesMicrobiologyMicroscopyMicrosoft ExcelMicrosoft OfficeMolecular & Cellular Biologymolecular biologyMolecular geneticsPharmaceutical IndustryPharmacodynamicsPharmacokineticsPharmacovigilancePharmacyPhase IPhase IIPhase IIIPhase IVPhases of clinical development (phase I to IV)PowerPointPre-clinical researchProcess improvementProduct developmentProtein chemistryProtein ExpressionProtein PurificationProtocolqPCRQualificationQuality Assurance (QA)Quality Control (QC)Quality ManagementR&DRegulatory affairsRegulatory RequirementsSDS-PAGEStatisticsTechnical reportsTechnical SupportTechnology transferTime ManagementTrainingTroubleshootingUnderstand how results translate to practiceUnderstanding of regulatory guidelinesValidationVerificationVirologyWriting Study Procedures and SOPsMass Spectrometry
LinkedIn Assessment :
ImmunoassaysAseptic TechniquesLaboratory Skillsgenetic engineeringGMPRegulatory affairsAnalytical Method ValidationFlow CytometryCell PhysiologyLean ToolsBioprocessingMedical DevicesValidationSpectrophotometryPolishProcess ChemistryQuality Control (QC)DNA extractionLAMP assay

Skills and Expertise

Self Assessment :
Analyze data Interpret data Molecular Diagnostics Report data Technology researchAdministrative supportAnalyze dataAnalyze proteinData analysisData entryEnsure data consistencylifescienceMaintenance of biomedical equipmentManage laboratory proceduresObserve trends in dataQuality control processResolves queriesSolve problemsSpecimen processingUse western blotting techniqueValidate dataVerify dataWork under specific instructions

Education

  • HETAC level 8 Certificate in Pharmecutical and Medical Devices Manufacturing from ITT & InnopharmaLabs in 2013
  • Master's degree in BIOTECHNOLOGY from University of Technology and Life Sciences Bydgoszcz in 2004

Training and Certification

  • MS Excel 2010 Specialist in 2015 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Elementary Proficiency
Polish
Native
English
Full Proficiency

Work Preferences

  • Notice Period:
    1 week
  • Work From Home:
    No
  • International:
    Yes

Area / Region

Zaventem, Belgium

Others

Driving License
  • Yes